ABX464 Maintenance Therapy for Ulcerative Colitis
Trial Summary
What is the purpose of this trial?
This is a multicenter, randomized, placebo-controlled study to evaluate the long-term efficacy and safety of ABX464 50mg and 25mg administered once daily (QD) as maintenance therapy in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies \[corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)\] and/or advanced therapies \[biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors\]. This study is the maintenance phase of both previous induction studies ABX464-105 and ABX464-106.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications, but it mentions that certain medications and procedures for ulcerative colitis are prohibited during the study. It's best to discuss your current medications with the study team to see if they are allowed.
How does the drug ABX464 differ from other drugs for ulcerative colitis?
ABX464 is unique because it is being studied as a maintenance therapy specifically for ulcerative colitis, which means it could help keep the disease in remission over the long term. Unlike some existing treatments that focus on reducing immune system activity, ABX464 may offer a novel approach, potentially improving adherence and reducing the need for corticosteroids.12345
Research Team
Severine Vermeire, MD, PhD
Principal Investigator
UZ Leuven, Belgium
Bruce Sands, MD, PhD
Principal Investigator
Mount Sinai Health System Digestive Disease Institute, New York USA
Eligibility Criteria
This trial is for people with moderate to severe ulcerative colitis who didn't get better with standard or advanced treatments. They must have finished a previous ABX464 study and can't be planning pregnancy soon. Participants need valid endoscopy results, agree to use effective contraception, sign consent forms, and commit to the study schedule.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Maintenance Treatment
Participants receive ABX464 25 mg or 50 mg or placebo once daily for 44 weeks
Long Term Extension
Participants can continue their allocated treatment for up to 4 years after the maintenance phase
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- ABX464
Find a Clinic Near You
Who Is Running the Clinical Trial?
Abivax S.A.
Lead Sponsor